Trial Outcomes & Findings for Swallowing Impairment After COVID-19 Infection (NCT NCT04537650)
NCT ID: NCT04537650
Last Updated: 2023-12-06
Results Overview
Frequency of participants demonstrating airway invasion on thin liquids, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996). Higher scores indicate worse function.
Recruitment status
COMPLETED
Target enrollment
44 participants
Primary outcome timeframe
Videofluoroscopy session (single timepoint only)
Results posted on
2023-12-06
Participant Flow
Participant milestones
| Measure |
COVID-19 Ventilated
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
36
|
|
Overall Study
COMPLETED
|
8
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
Baseline characteristics by cohort
| Measure |
COVID-19 Ventilated
n=8 Participants
This was a group of Community-Dwelling adults who had a history of COVID-19 infection prior to October, 2021 and who were hospitalized and required ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This was a group of Community-Dwelling adults who had a history of COVID-19 infection prior to October, 2021 but who did not require mechanical ventilation during their COVID-19 infection.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=8 Participants
|
44 years
n=36 Participants
|
48 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=8 Participants
|
30 Participants
n=36 Participants
|
31 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
6 Participants
n=36 Participants
|
13 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=8 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=8 Participants
|
34 Participants
n=36 Participants
|
41 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=8 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=8 Participants
|
33 Participants
n=36 Participants
|
38 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=8 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=44 Participants
|
|
Taste or Smell Impairment
YES (Taste/Smell impairment)
|
7 Participants
n=8 Participants
|
13 Participants
n=36 Participants
|
20 Participants
n=44 Participants
|
|
Taste or Smell Impairment
NO (No Taste/Smell impairment)
|
1 Participants
n=8 Participants
|
23 Participants
n=36 Participants
|
24 Participants
n=44 Participants
|
|
SSQ
|
98 units on a scale
n=6 Participants • Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
|
232 units on a scale
n=24 Participants • Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
|
158 units on a scale
n=30 Participants • Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
|
|
Time since diagnosis
|
6 Months
n=8 Participants
|
7 Months
n=36 Participants
|
7 Months
n=44 Participants
|
|
Tongue Weakness
|
3 Participants
n=8 Participants
|
8 Participants
n=36 Participants
|
11 Participants
n=44 Participants
|
|
Reduced peak cough flow
|
1 Participants
n=8 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=44 Participants
|
|
Fail water swallow screen (3 sips)
|
4 Participants
n=8 Participants
|
14 Participants
n=36 Participants
|
18 Participants
n=44 Participants
|
|
Fail water swallow screen (90cc)
|
3 Participants
n=8 Participants
|
13 Participants
n=36 Participants
|
16 Participants
n=44 Participants
|
|
SSQ Impaired
|
1 Participants
n=6 Participants • Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
|
12 Participants
n=24 Participants • Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
|
13 Participants
n=30 Participants • Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.
|
PRIMARY outcome
Timeframe: Videofluoroscopy session (single timepoint only)Frequency of participants demonstrating airway invasion on thin liquids, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996). Higher scores indicate worse function.
Outcome measures
| Measure |
COVID-19 Ventilated
n=8 Participants
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Number of Participants With Impaired Swallowing Safety
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Videofluoroscopy session (single timepoint only)Frequency of participants demonstrating pharyngeal residue on extremely thick liquids measured to fill more than 1.5% of an anatomical reference scalar \[%(C2-4)squared\] (Steele et al., 2019)
Outcome measures
| Measure |
COVID-19 Ventilated
n=8 Participants
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Number of Participants With Impaired Swallowing Efficiency
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Videofluoroscopy session (single timepoint only)Frequency of participants displaying prolonged time to airway closure (i.e. Laryngeal Vestibule Closure) on thin liquids, defined as values falling above the healthy reference 75th percentile (Steele et al., 2023)
Outcome measures
| Measure |
COVID-19 Ventilated
n=8 Participants
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure
|
6 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Videofluoroscopy session (single timepoint only)Frequency of participants displaying short airway closure (i.e. laryngeal vestibule closure) on thin liquids, defined as a duration below the healthy reference 25th percentile (Steele et al., 2023)
Outcome measures
| Measure |
COVID-19 Ventilated
n=8 Participants
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Number of Participants With Short Laryngeal Vestibule Closure Duration
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Videofluoroscopy session (single timepoint only)Frequency of participants displaying poor pharyngeal constriction on extremely thick liquids, defined as pharyngeal area above the 75th percentile healthy reference value on the frame of maximum constriction (Steele et al., 2023)
Outcome measures
| Measure |
COVID-19 Ventilated
n=8 Participants
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Number of Participants With Poor Pharyngeal Constriction
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Videofluoroscopy (single timepoint only)Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.
Outcome measures
| Measure |
COVID-19 Ventilated
n=8 Participants
This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection
|
COVID-19 Non-ventilated
n=36 Participants
This group of participants did not require mechanical ventilation during their COVID-19 infection
|
|---|---|---|
|
Number of Participants With Impaired LVC Integrity
|
1 Participants
|
0 Participants
|
Adverse Events
COVID-19 Ventilated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COVID-19 Non-ventilated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Catriona M. Steele, PhD
KITE Research Institute - University Health Network
Phone: 14165973422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place